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Completed

NCT Number: NCT04205773

Epidural Catheter Location by Epidural Pressure Waveform

The aim of this preliminary study was to evaluate the new CompuFlo instrument which allows pulsatile waveform recordings.

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Key information

Conditions

Anesthesia, Local

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

EESOA Maternal Neonatal Simulation Centre, Roma, Italy

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About this study

30 epidural catheters previously successfully used for obstetric anesthesia or analgesia and about to be removed were tested. All patients were given 5 mL 2% lidocaine to test the catheter before its removal. After priming with 5 mL saline, the catheter was connected to CompuFlo to record the occurrence of pulsatile waveforms and/or their disappearance during its removal. The epidural catheter was marked at the skin level to record the distance between the skin at the time of measurements. The power analysis required a sample of 30 observations to set 80% test power and 95% significance level.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Obstetric patients
  • Must have an epidural catheter

Exclusion criteria

  • Non-obstetric patients

Treatment and study plan

CompuFlo

Device

After priming with 5 mL saline, the catheter was connected to CompuFlo to record the occurrence of pulsatile waveforms and/or their disappearance during its removal

Primary outcomes

  1. pulsatile waveforms observation (presence or absence)

    Time frame: 30 minutes

    The epidural catheter was considered to be in the epidural space if the appearance of pulsatile waveforms were observed, and confirmed by the occurrence of L2-3 sensory block after the test dose. The disappearance of the pulsatile waveforms when the catheter was extracted from the epidural space was also noted.

Sponsors and collaborators

Lead sponsor

European e-Learning School in Obstetric Anesthesia

Other

Registry information

Official study title

Confirmation of Epidural Catheter Location by Epidural Pressure Waveform Recordings by the CompuFlo Epidural Instrument

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 19, 2019
Registry last updated
Dec 20, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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